Clinical trial
A Randomized Phase II Study to Evaluate the Incidence of Discontinuations Due to Diarrhoea at 3 Cycles in Patients With Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer Treated With Neratinib Plus Loperamide Prophylaxis Versus Neratinib With Initial Dose Escalation Plus PRN Loperamide Prophylaxis Versus Neratinib Plus Loperamide Plus Colesevelam Prophylaxis "DIANER Study"
NCT05252988 is registered in ClinicalTrials.gov with Spanish Breast Cancer Research Group as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Randomized Phase II Study to Evaluate the Incidence of Discontinuations Due to Diarrhoea at 3 Cycles in Patients With Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer Treated With Neratinib Plus Loperamide Prophylaxis Versus Neratinib With Initial Dose Escalation Plus PRN Loperamide Prophylaxis Versus Neratinib Plus Loperamide Plus Colesevelam Prophylaxis "DIANER Study"
- Lead sponsor
- Spanish Breast Cancer Research Group
- Phase
- Phase 2
- Overall status
- Active, not recruiting
- Start date
- August 31, 2022
- Completion date
- January 31, 2030
- Enrollment
- 177 (actual)
- Sites
- 55
Conditions
As the registry lists them; a condition with its own page is linked.
early-stage breast cancer, her2 positive breast cancer, hormone receptor positive